A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

Sponsor

Taiho Oncology, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04586270

Collaborator

(none)

242

Enrollment

Locations

Arms

43.5

Anticipated Duration (Months)

80.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

Condition or Disease	Intervention/Treatment	Phase
Advanced or Metastatic Solid Tumors	Drug: TAS0612	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

242 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAS0612 Escalation TAS0612 administered orally	Drug: TAS0612 oral tablets
Experimental: TAS0612 Expansion TAS0612 administered orally	Drug: TAS0612 oral tablets

Arm

Intervention/Treatment

Experimental: TAS0612 Escalation

TAS0612 administered orally

Drug: TAS0612

oral tablets

Experimental: TAS0612 Expansion

TAS0612 administered orally

Drug: TAS0612

oral tablets

Outcome Measures

Primary Outcome Measures

Dose Limiting Toxicities (DLTs) [Baseline through Cycle 1 (28 day cycle)]
Number of participants with DLTs during cycle 1
Objective Response Rate [Baseline through measured progressive disease (estimated up to 24 months)]
Percentage of participants with partial response (PR) or complete response (CR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Outcome Measures

Disease Control Rate (DCR) [Baseline through progressive disease (estimated up to 24 months)]
DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.
Duration of Response (DOR) [Estimated up to 22 months]
DOR: Date of PR or CR to date of objective progression or death due to any cause.
Progression Free Survival (PFS) [Estimated up to 24 months]
Baseline to objective progression or death due to any cause.
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of TAS0612 [Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle)]
Cmax of TAS0612
Pharmacokinetics (PK): plasma concentration of TAS0612 [Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle)]
Plasma concentration of TAS0612
PK: Area under the plasma concentration curve (AUC) [Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle)]
AUC of TAS0612
PK: Time it takes to reach Cmax (Tmax) of TAS0612 [Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle)]
Tmax of TAS0612
PK: Time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612 [Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle)]
t1/2 of TAS0612
Safety and Tolerability [Estimated up to 24 months]
All adverse events (AEs) per CTCAE v5.0
Pharmacodynamic: biochemical effects of TAS0612 [Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle)]
Total proteins and phospho-proteins will be measured in blood samples collected at different time points. The levels/changes (dose- and concentration-dependent) of phospho-proteins will be assessed and reported for biochemical effects of TAS0612.
Pharmacodynamic: molecular effects in tumor tissue of TAS0612 [Baseline through Day 1 Cycle 2 (28-day cycle)]
Selected phospho-proteins will be analyzed in tumor tissue at baseline and on-treatment in dose escalation. The levels/changes of the phospho-proteins will be assessed and reported for target modulation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Dose Escalation: have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)
Dose Expansion: have evidence of a solid tumor as outlined below that is locally advanced and/or metastatic (excluding primary brain tumor)
Cohort A: Human epidermal growth factor negative (HER2 negative) Breast Cancer with an NF1 mutation
Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor
Cohort C: PTEN loss or mutations
Cohort D: KRAS G12C mutation
Cohort E: KRAS G12D mutation
Have adequate organ function
Amenable to biopsy
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

Participating in medical research not compatible with this study
Have not discontinued or recovered from previous treatments for cancer
Have a significant cardiac condition
Have untreated brain metastases
Have a primary brain tumor
Have a serious concomitant disorder
Unable to swallow or digest pills
Poorly controlled diabetes
Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Oncology	Nashville	Tennessee	United States	37203
2	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
3	Centre de Lutte Contre le Cancer Gustave Roussy	Villejuif	Cedex	France	94805